Trial · NCT06378866
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
NCT06378866, Phase 2, Recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial. Trials, record NCT06378866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06378866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
- NCT number
- NCT06378866
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 532 participants, estimated
- Lead sponsor
- Mayo Clinic
- Conditions
- Recurrent Castration-Sensitive Prostate Carcinoma, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer, Biochemically Recurrent Prostate Carcinoma
- Interventions
Abiraterone, Apalutamide, Biospecimen Collection, Bone Scan, Computed Tomography, Darolutamide, Degarelix, Enzalutamide, Goserelin, Histrelin, Leuprolide, Magnetic Resonance Imaging, Patient Observation, Positron Emission Tomography, Prednisone, Questionnaire Administration, Relugolix, Stereotactic Body Radiation Therapy, Triptorelin, Radiation Therapy, Image-Guided Therapy
- First posted
- 2024-04-23
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified radiographic progression-free survival (mrPFS) (Groups A & B) | Up to 5 years | Modified radiographic progression-free survival (mrPFS) is defined as the time from the date of randomization (enrollment to study) to the date of the first occurrence of the following events: death due to all causes or radiographic progression per Prostate Cancer Working Group 3 Criteria, which is not addressable by stereotactic body radiation therapy (SBRT). Radiographic progression not addressable by SBRT per the treating physician NOTE: Radiographic progression disease that can be addressed by SBRT will not be an mrPFS event. NOTE: Event-free patients will be censored at their last imaging assessment. |
| Primary | Distant progression-free survival (PFS) (Groups C & D) | Up to 5 years | Defined as the date from the date of randomization + 1 year to the date of the first occurrence of death due to all causes or distant progression. Local progression will NOT be considered a distant progression event. Event-free patients will be censored at their last imaging assessment or prostate-specific antigen evaluation, whichever is later. |
| Secondary | Overall survival (OS) | Up to 5 years | Defined as time from randomization (enrolled to study) to the date of death due to any cause. Will be conducted on modified intent-to-treat (mITT) and per-protocol (PP) populations whenever it is applicable and plausible. Safety-related analyses will be performed on the safety population. |
| Secondary | Biochemcial progression-free survival (bPFS) | Up to 5 years | Defined as the time from randomization (enrollment to study) up to the date of death due to any cause or biochemical progressive disease, whichever occurs first. Will be conducted on mITT and PP populations whenever it is applicable and plausible. Safety-related analyses will be performed on the safety population. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42117295 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01CA300454 | Blood-based tumor and immune markers for risk stratification and monitoring treatment response in oligometastatic prostate cancer | Park, Sean S; Chaudhuri, Aadel; Lucien-Matteoni, Fabrice | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2026 | NIH RePORTER |
| R01CA286127 | Novel ctDNA biomarker for androgen therapy in metastatic prostate cancer | MAHER, CHRISTOPHER A; CHAUDHURI, AADEL; PACHYNSKI, RUSSELL K. | WASHINGTON UNIVERSITY | NATIONAL CANCER INSTITUTE | 2024 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06378866
GET https://conductscience.org/api/trials/v1/NCT06378866/registered